The National Consumers League supports the bipartisan S 4918 (117th Congress) “Increasing Prescription Drug Competition Act”

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February 7, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – NCL is the nation’s oldest consumer and worker advocacy organization, formed in 1899 to work for a fair marketplace for all. NCL has long supported robust competition and affordable, accessible drugs for patients and consumers. We therefore appreciate the opportunity to provide our support for the bill introduced in the 117th Congress entitled “Increasing Prescription Drug Competition Act”, co-sponsored by Senator Maggie Hassan (D-NH) and Senator Mike Braun (R-IN). This legislation would bar the use of various loopholes in the law to block the introduction and sale of competitor drugs. One such familiar technique brand drug makers have used is claiming that a REMS programs (Risk Evaluation and Mitigation Strategies) required by the FDA for the brand version of the drug, prevents a competitor drug from entering the market. This argument goes against the prevailing view within the FDA and the FTC that a REMS requirement on the brand name drug must not be used as a way to block competition.

The Federal Trade Commission voted 4-0 to file an amicus brief  with the U.S. District Court for the District of Delaware on this topic.  The FTC brief takes no position on the scope or claim construction of the patent, but argues generally that there is significant harm to consumers when a brand lists a patent on a distribution system in the Food and Drug Administration’s “Orange Book” of approved drugs and thereby blocks the introduction of lower-cost generic medications or other follow-on competition. The FTC’s amicus brief explains how the Orange Book listing process can be abused, and emphasizes the harm to competition and consumers that can result from that abuse, including depriving consumers of potential competition from lower-cost alternatives and the ability to choose between products.

By way of background, we note these additional points:

  • REMS, or Risk Evaluation and Mitigation Strategies, are required by FDA for certain medications to ensure that the benefits of the drug outweigh its risks.  The sole purpose of a REMS is to protect patient safety
  • Despite policies that the former FDA Commissioner, Dr. Scott Gottlieb announced in 2018 to reduce the use of REMS programs as a way to block competition and access, followed by the CREATES act, which was signed into law in 2019, loopholes remain today
  • We look forward to the reintroduction of the bi-partisan bill proposed last fall by Senator Hassan (D-NH)and Senator Braun (R-IN), “Increasing Prescription Drug Competition Act”, which would no longer allow FDA approvals of medications to be delayed due to patents listed in the FDA “Orange Book” on REMS
  • We hope the legislation will address the problem of companies taking advantage of FDA-mandated safety programs at the expense of patients receiving innovative competitor medications, or generic medications. We believe that “Increasing Prescription Drug Competition Act”, bill will help to address that problem.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit https://nclnet.org.

NCL statement on FDA decision regarding CBD regulatory framework

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January 27, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – The National Consumers League (NCL), the nation’s oldest consumer advocacy organization, applauds the FDA’s decision that “a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”

NCL has been actively monitoring the growing threats to consumer safety as the market for untested, unapproved cannabidiol (CBD) products has exploded.

“This announcement is a critical step in the right direction. NCL supports FDA’s assessment that the existing dietary supplement and conventional food pathways are not appropriate for CBD,” said NCL Executive Director Sally Greenberg. “We are encouraged to see regulators prioritizing science and consumer safety, and we are committed to working with Congress, the FDA and other stakeholders to explore potential regulatory pathways that prioritize management of health risks associated with CBD and acceleration of rigorous research into cannabinoids’ therapeutic potential.”

“To that end, NCL was pleased to see FDA highlight the need for risk management tools, including clear labels, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children.”

Along with our partners – the Consumer Federation of America and the Community Anti-Drug Coalitions of America – NCL created the Consumers for Safe CBD in 2019, now Cannabis Consumer Watch, to educate consumers about the potential dangers of CBD in an unregulated market.

“We will continue advocating for policies that preserve meaningful, scientific research incentives while protecting public health,” Greenberg said. “As Congress works to develop a new regulatory pathway for CBD, it is critical that we bear in mind there’s greater urgency to address the risks posed by intoxicating cannabinoid products in the hemp market. As we’ve seen, these products pose significant risks to consumers, and must be addressed. Science should continue to guide policy discussions to ensure a safe and effective regulatory pathway.”

To learn more, visit cannabiswatch.org.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit https://nclnet.org.

National Consumers League applauds FDA’s decision increasing access to Mifepristone (the “abortion pill”)

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January 5, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – The Food and Drug Administration (FDA)’s decision this week to lift a major barrier blocking access to medication abortion care marks an important step forward for women.  Mifepristone is a drug that blocks the hormone needed for a pregnancy to continue. Mifepristone, when used together with another medicine called misoprostol, is used to end a pregnancy through ten weeks gestation.  And it is safe.

The FDA posted the following on its website: “Mifepristone is safe when used as indicated and directed and consistent with the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. The FDA approved Mifeprex more than 20 years ago based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use.  As of 2016, it can be used for medical termination of pregnancy up to 70 days of gestation.  The FDA’s periodic reviews of the postmarketing data for Mifeprex and its approved generic have not identified any new safety concerns with the use of mifepristone for medical termination of pregnancy through 70 days gestation. As with all drugs, the FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of pregnancy.”

NCL urges continuous attention on this issue. While FDA moved things forward by expanding access, too many people remain without care options because they live in states that ban telehealth for medication abortion or have banned abortion outright.

FDA’s lifting of the in-person dispensing requirement and establishing a new program to certify both brick-and-mortar and mail-order pharmacies to dispense mifepristone is a turning point for so many, especially young women and women in abusive relationships who may not have the privacy to receive medication by mail.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit https://nclnet.org.

NCL welcomes FDA heightened concerns related to CBD products

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December 29, 2022 [Updated]

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 703-298-2614

Washington, D.C. – The National Consumers League (NCL), the nation’s oldest consumer advocacy organization, is welcoming of the FDA’s heightened concern and attention to consumer safety risks in the CBD or cannabidiol consumer product market.

“The FDA’s continued engagement and work in the CBD consumer product market is critical to protecting consumer safety – the agency’s increased attention to CBD products is welcome news,” said Sally Greenberg, NCL’s Chief Executive Officer.

In 2019, in response to the proliferation of unreviewed and untested CBD products, NCL identified the need for greater education among consumers about CBD and better enforcement of regulations in the CBD marketplace. NCL created Consumers for Safe CBD to address this need, champion the rights of consumers, and call on government and industry to do better – to ensure safety and promote a pathway for new products through clinically tested scientific research.

Since then, action has been taken on the state and federal levels to increase access to cannabinoids beyond CBD, which is why NCL is now shifting its focus to cannabis more broadly with the establishment of Cannabis Consumer Watch. Cannabidiol (CBD) is a chemical compound found in cannabis plants. It is one of the main ingredients in cannabis, but unlike THC, it does not cause a high or have psychoactive effects.

“NCL called on the FDA to develop regulations for the CBD marketplace. We also asked the CBD industry to ensure safety and promote a pathway for new products through clinically tested scientific research,” said Greenberg.

The 2018 Farm Bill legalized hemp cultivation in the U.S., which led to significant growth in the CBD marketplace.

“Since 2019, NCL and other groups like the Consumer Federation of America and Community Anti-Drug Coalitions of America have been asking the FDA to step in and address the CBD marketplace – which is currently a ‘Wild West,’ with myriad unsubstantiated claims made by many in the industry about the so-called benefits of CBD products for everything from sleep disorders to cancer to pain relief, without regard to safe dosages,” Greenberg noted. “We want the agency to establish a regulatory framework for the legal sale of appropriate cannabis and cannabis-derived products. Some industry members have been asking for rules of the road as well. Any regulatory framework FDA recommends for cannabis-derived products must prioritize consumer safety and address the safety risks the agency has identified.”

There is only one FDA-approved drug on the market that employs CBD as its active ingredient – Epidiolex – a medication to treat a rare form of childhood epilepsy. That drug has undergone the rigorous FDA approval process and thus has substantiated therapeutic benefits that outweigh the risks which can be managed by prescribing physicians.

Cannabis Consumer Watch will continue to work to educate consumers about the potential dangers of CBD in an unregulated market and encourage the FDA to take strong, effective, and prompt action to protect the public from the potential harms posed by unregulated, untested CBD.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit https://nclnet.org.

DeSantis’s anti-vax claims are wrong and dangerous, says NCL

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December 22, 2022

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 703-298-2614

WASHINGTON, D.C. – The National Consumers League was very disappointed to learn that Florida Governor Ron DeSantis recently announced that he is requesting a statewide grand jury investigation into alleged “crimes and wrongdoings” relating to the COVID-19 vaccine. He is forming a public health policy committee whose charge is to review public health recommendations and guidance made by federal health experts and agencies like the Food and Drug Administration and the Centers for Disease Control and Prevention (CDC). The committee will be overseen by the state’s Surgeon General Joseph Ladapo, who himself has repeatedly made anti-vaccination claims.

“For a public official of Governor DeSantis’s stature to make these baseless anti-vaccination claims is wrong and dangerous,” says NCL Chief Executive Officer Sally Greenberg. “The governor has reversed course from supporting the roll out of the COVID vaccine and now is raising questions, against all scientific evidence, about the efficacy and safety of these critically important medicines. COVID vaccinations have been found overwhelmingly effective in reducing the risk of infection from the SARS-CoV-2 virus, which has killed more than 1 million Americans, most of whom were unvaccinated.”

In a study of  4,000 healthcare personnel, police, firefighters, and other essential workers, the CDC found that the vaccines reduced the risk of infection by 80 percent after one shot. Protection increased to 90 percent following the second dose. The findings are consistent with clinical trial results and studies showing strong effectiveness in Israel and the United Kingdom, and in initial studies of healthcare workers at the UT Southwestern Medical Center and in Southern California.

Protecting public health remains one of NCL’s focus, and vaccinations are one of the most effective public health prevention tools available to keep consumers and workers safe from severe and potentially deadly diseases.

We call upon all officials – including Governor DeSantis – who hold positions of responsibility and visibility, to rely on evidence-based medicine and science before making unfounded claims.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit https://nclnet.org.

The National Consumers League mourns the death of NCL Awardee, labor champion and writer, Barbara Ehrenreich

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September 6, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832 

WASHINGTON, D.C. – The National Consumers League is mourning the death of one of our Trumpeter Awardees, best-selling author of Nickel and Dimed, and hourly worker champion Barbara Ehrenreich.  Ehrenreich accepted NCL’s Trumpeter Award in 2008, which was presented because of her writing on behalf of the working poor.  In Nickel and Dimed,  Ehrenreich traveled around the country working minimum wage jobs and writing about how very difficult that was to do; she wrote a compelling narrative about impossibility of making ends meet, even as a single woman, living on jobs like restaurant server and hotel maid. She described in graphic detail the daily grind and many demeaning experiences she encountered.

NCL Executive Director Sally Greenberg speaks to her immense impact on the labor industry, “Barbara Ehrenreich talked the talk, and walked the walk with her long and admirable history of raising awareness about the plight of working Americans.  Nickel and Dimed showed the world just how difficult it is to live on subsistence wages, find housing, health care, buy food, own a car and then have to go to work. She pulled the veil off of the faulty notion that working people can comfortably live off minimum wage jobs. We owe her a debt of gratitude for putting her life on hold to work these jobs and write about the economic reality for working people.”

NCL was honored to have Ehrenreich at our annual Trumpeter Dinner in 2008, present her with the Trumpeter Award, and we mourn her passing this past Labor Day holiday.

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About the National Consumers League (NCL) 

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Airline hotel and meal voucher commitments are a positive step forward

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September 2, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832 

WASHINGTON, D.C. – The National Consumers League (NCL) welcomes the major U.S. airlines’ commitments to provide meals and hotel rooms for travelers stranded due to delays within air carriers’ control. This announcement comes as consumer and passenger rights organizations have advocated for greater protections for travelers within the aviation industry.

The following statement is attributable to NCL Executive Director Sally Greenberg:   

“In July 2021, NCL, alongside a coalition of other consumer and passenger rights groups, met with Transportation Secretary Pete Buttigieg. A key ask to him was to publicly and personally make the DOT’s airline consumer protection work a priority. As today’s announcement shows, he is taking our challenge to heart. Absent pressure from the Department of Transportation, driven by an unprecedented wave of consumer complaints, it is hard to imagine that the biggest U.S. airlines would have made a commitment to provide meal and hotel vouchers and reimbursement to stranded consumers. While there is much more work to be done achieving a range of consumer protection reforms in the airline industry, today’s news is a positive step forward.” 

 

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About the National Consumers League (NCL) 

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

National Consumers League applauds President Biden’s plan to cancel $10,000 in federal student loan debt to millions of Americans

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August 24, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832 

WASHINGTON, D.C. – The National Consumers League applauds President Biden’s decision to relieve student borrowers of billions of dollars in educational debt and to extend the federal loan repayment moratorium. By cancelling $10,000 in student debt for borrowers earning less than $125,000 and cancelling $20,000 for borrowers who received Pell Grants, this administration is providing direct aid to consumers suffering from the plight of educational debt.

The following statement is attributable to NCL Executive Director Sally Greenberg:

“President Biden is providing critical assistance to millions of borrowers across the country. Importantly, this executive order will work to negate the impact of student debt that disproportionately affects women and Black borrowers. As consumers face increased rents, grocery costs, fuel prices, and even student loan interest rates, educational debt cancellation will help provide relief on strained household budgets by reducing—and in many cases eliminating—student debt costs.”

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About the National Consumers League (NCL) 

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.